IP Library Granted Patent US 12,194,095
Granted Patent B2
US 12,194,095 · App. 17/545,274 · Granted Jan 14, 2025

Combinations and uses thereof

Inventors: Jan Endell (Munich, DE); Mark Winderlich (Munich, DE); Rainer Boxhammer (Aying, DE)
Assignee: Incyte Corporation
A61K39/39558A61K39/395A61P35/02C07D403/12C07D473/16C07K16/2803A61K2300/00C07K2317/565C07K2317/73
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Quick Facts
Patent No.
US 12,194,095
App. No.
17/545,274
Granted
Jan 14, 2025
Kind
B2
Abstract

The present disclosure describes a pharmaceutical combination of an anti-CD19 antibody and a phosphoinositide 3-kinase inhibitor for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia and/or acute lymphoblastic leukemia.

Claims (106)

1. A method for treatment of non-Hodgkin's lymphoma in a patient in need thereof, said method comprising administering to the patient idelalisib and an antibody specific for CD19,

wherein said antibody comprises:

a variable heavy chain of the sequence

(SEQ ID NO: 10)

EVQLVESGGGLVKPGGSLKLSCAASGYTFTSYVMHWVRQAPGKGLEWIGY

INPYNDGTKYNEKFQGRVTISSDKSISTAYMELSSLRSEDTAMYYCARGT

YYYGTRVFDYWGQGTLVTVSS;

a variable light chain of the sequence

(SEQ ID NO: 11)

DIVMTQSPATLSLSPGERATLSCRSSKSLQNVNGNTYLYWFQQKPGQSPQ

LLIYRMSNLNSGVPDRFSGSGSGTEFTLTISSLEPEDFAVYYCMQHLEYP

ITFGAGTKLEIK;

a heavy chain constant domain of the sequence

(SEQ ID NO: 12)

ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGV

HTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEP

KSCDKTHTCPPCPAPELLGGPDVFLFPPKPKDTLMISRTPEVTCVVVDVS

HEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQDWLNGK

EYKCKVSNKALPAPEEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTC

LVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRW

QQGNVFSCSVMHEALHNHYTQKSLSLSPGK;

and

a light chain constant domain of the sequence

(SEQ ID NO: 13)

RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSG

NSQESVTEQDSKD STYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVT

KSFNRGEC.

2. The method of claim 1 , wherein said antibody specific for CD19 and idelalisib are administered separately.

3. The method of claim 1 , wherein said antibody specific for CD19 and idelalisib are administered separately physically.

4. The method of claim 1 , wherein said antibody specific for CD19 and idelalisib are administered separately in time.

5. The method of claim 1 , wherein said antibody specific for CD19 and idelalisib are administered together.

6. The method of claim 1 , wherein idelalisib is administered prior to administration of the antibody specific for CD19.

7. The method of claim 1 , wherein idelalisib is administered after administration of the antibody specific for CD19.

8. The method of claim 1 , wherein the non-Hodgkin's lymphoma is follicular lymphoma.

9. The method of claim 1 , wherein the non-Hodgkin's lymphoma is small lymphocytic lymphoma.

10. The method of claim 1 , wherein the non-Hodgkin's lymphoma is mucosa-associated lymphoid tissue lymphoma.

11. The method of claim 1 , wherein the non-Hodgkin's lymphoma is marginal zone lymphoma.

12. The method of claim 1 , wherein the non-Hodgkin's lymphoma is diffuse large B cell lymphoma.

13. The method of claim 1 , wherein the non-Hodgkin's lymphoma is Burkitt's lymphoma.

14. The method of claim 1 , wherein the non-Hodgkin's lymphoma is mantle cell lymphoma.

15. A method for treatment of chronic lymphocytic leukemia in a patient in need thereof, said method comprising administering to the patient idelalisib and an antibody specific for CD19,

wherein said antibody comprises:

a variable heavy chain of the sequence

(SEQ ID NO: 10)

EVQLVESGGGLVKPGGSLKLSCAASGYTFTSYVMHWVRQAPGKGLEWIGY

INPYNDGTKYNEKFQGRVTISSDKSISTAYMELSSLRSEDTAMYYCARGT

YYYGTRVFDYWGQGTLVTVSS;

a variable light chain of the sequence

(SEQ ID NO: 11)

DIVMTQSPATLSLSPGERATLSCRSSKSLQNVNGNTYLYWFQQKPGQSPQ

LLIYRMSNLNSGVPDRFSGSGSGTEFTLTISSLEPEDFAVYYCMQHLEYP

ITFGAGTKLEIK;

a heavy chain constant domain of the sequence

(SEQ ID NO: 12)

ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGV

HTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEP

KSCDKTHTCPPCPAPELLGGPDVFLFPPKPKDTLMISRTPEVTCVVVDVS

HEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQDWLNGK

EYKCKVSNKALPAPEEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTC

LVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRW

QQGNVFSCSVMHEALHNHYTQKSLSLSPGK;

and

a light chain constant domain of the sequence

(SEQ ID NO: 13)

RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSG

NSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTK

SFNRGEC.

16. The method of claim 15 , wherein said antibody specific for CD19 and idelalisib are administered separately.

17. The method of claim 15 , wherein said antibody specific for CD19 and idelalisib are administered separately physically.

18. The method of claim 15 , wherein said antibody specific for CD19 and idelalisib are administered separately in time.

19. The method of claim 15 , wherein said antibody specific for CD19 and idelalisib are administered together.

20. The method of claim 15 , wherein idelalisib is administered prior to administration of the antibody specific for CD19.

21. The method of claim 15 , wherein idelalisib is administered after administration of the antibody specific for CD19.

22. A method for treatment of acute lymphoblastic leukemia in a patient in need thereof, said method comprising administering to the patient idelalisib and an antibody specific for CD19,

wherein said antibody comprises:

a variable heavy chain of the sequence

(SEQ ID NO: 10)

EVQLVESGGGLVKPGGSLKLSCAASGYTFTSYVMHWVRQAPGKGLEWIGY

INPYNDGTKYNEKFQGRVTISSDKSISTAYMELSSLRSEDTAMYYCARGT

YYYGTRVFDYWGQGTLVTVSS;

a variable light chain of the sequence

(SEQ ID NO: 11)

DIVMTQSPATLSLSPGERATLSCRSSKSLQNVNGNTYLYWFQQKPGQSPQ

LLIYRMSNLNSGVPDRFSGSGSGTEFTLTISSLEPEDFAVYYCMQHLEYP

ITFGAGTKLEIK;

a heavy chain constant domain of the sequence

(SEQ ID NO: 12)

ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGV

HTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEP

KSCDKTHTCPPCPAPELLGGPDVFLFPPKPKDTLMISRTPEVTCVVVDVS

HEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQDWLNGK

EYKCKVSNKALPAPEEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTC

LVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRW

QQGNVFSCSVMHEALHNHYTQKSLSLSPGK;

and

a light chain constant domain of the sequence

(SEQ ID NO: 13)

RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSG

NSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTK

SFNRGEC.

23. The method of claim 22 , wherein said antibody specific for CD19 and idelalisib are administered separately.

24. The method of claim 22 , wherein said antibody specific for CD19 and idelalisib are administered separately physically.

25. The method of claim 22 , wherein said antibody specific for CD19 and idelalisib are administered separately in time.

26. The method of claim 22 , wherein said antibody specific for CD19 and idelalisib are administered together.

27. The method of claim 22 , wherein idelalisib is administered prior to administration of the antibody specific for CD19.

28. The method of claim 22 , wherein idelalisib is administered after administration of the antibody specific for CD19.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 22, 2024
From: MORPHOSYS AG; MORPHOSYS US INC.
To: INCYTE CORPORATION
Reel/Frame 066645/0172 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 16, 2021
From: ENDELL, JAN; WINDERLICH, MARK; BOXHAMMER, RAINER
To: MORPHOSYS AG.
Reel/Frame 058407/0955 →
Priority Claims (1)
EP 15181925 · Aug 21, 2015 · regional
Continuity (2)
Continuation 15752009
Related Publication 20220088197A1 · Mar 24, 2022
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